MES Operations Engineer

Job Description:

The MES Operations Engineer responsible for analyzing and supporting various manufacturing applications, ensuring manufacturing continuity, and facilitating process improvements. They will bridge the gap between IT systems, production operations, and engineering teams to ensure MES implementations enable efficiency, quality, traceability, and compliance across manufacturing lines.

This role requires a comprehensive understanding of manufacturing processes and collaboration with multiple departments to deliver high-quality results in a fast-paced manufacturing environment.

The position requires hands-on shop-floor engagement, cross-functional leadership, and strong problem solving to deliver measurable business outcomes. The role will also be part of different project initiatives as a project resource.

Responsibilities:

• Providing ongoing support and address user inquiries related to internal MES systems
• Understanding of how different systems may be interfaced and the flow of data between systems
• Keep documentation up to date with any system changes or updates
• Implement and adhere to GMP practices, ISO 13485, and FDA regulations (e.g., 21 CFR Part 820); support validations (IQ/OQ/PQ) and audit readiness.
• Leverage MES capabilities such as electronic Device History Records (eDHR) and electronic Batch Records (eBR) to enforce production processes and capture complete as-built records.
• Work closely with manufacturing engineers to analyze workflows, identify requirements, and translate them into technical specifications. Design solutions for production tracking, quality management, and inventory control, supporting continuous improvement and lean manufacturing initiatives.
• Participate in Kaizens and process improvement activities aligned with the Business Solutions Roadmap
• Collaborate with process engineering, quality, IT, supply chain, and manufacturing departments to ensure continuity
• Work independently and as part of a team to identify and address issues proactively
• Engage frequently with stakeholders across engineering, supply chain, quality, operations, and external partners; represent the organization on complex technical topics.
• Present technical information clearly to technical staff and management; influence cross-functional teams and mentor junior engineers/technicians.
• Provide work direction and ensure alignment with key leaders; collaborate within Innovation & Development (I&D) or similar functions to meet commitments.

Job Requirements:

Qualifications:

• Bachelor of Science in Engineering (Industrial, Mechanical, Electrical, Chemical, Systems or related). Equivalent education/experience considered.
• 3+ years of experience in a manufacturing environment; medical device or life sciences preferred.
• Experience with MES validation (IQ/OQ/PQ).
• Minimum 2 years under GMP in a regulated environment.
• Hands-on experience implementing and/or owning MES (e.g., Siemens Opcenter, Critical Manufacturing, SAP, Tulip, Rockwell Automation Plex).

Skills:

• Lean Six Sigma methods; project management; cross-functional influence.
• Knowledge of FDA regulations, ISO 13485, and validation practices; ability to implement regulatory requirements as necessary.
• Knowledge integrating MES with ERP (SAP), PLM, SCADA/automation
• Working knowledge of SAP
• Experience in a medical device manufacturing company

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Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.  At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

$83,400 - $118,200

Operating Company:

Nobel Biocare

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.  Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes.  An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.  Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.